Manufacturing Systems, Single-Use

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

QF20kSU single-use pumps from Quattroflow are used for applications requiring gentle product handling, high containment, low pulsation, purity, and cleanability.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.

Meissner’s QuaDrum rigid outer containers for its single-use assemblies can be used with standard, access, or retaining lids.

A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

GE and Sealed Air extend their long-term collaboration to develop single-use films purposefully constructed for bioprocessing applications.

The company announced that it will be expanding its portfolio of single-use vessels for fermentation.

Gamma-stable fluoropolymers are an alternative material for single-use bags and assemblies in biopharmaceutical manufacturing.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Customized puresu single-use fluid path assemblies from Watson-Marlow Fluid Technology Group incorporate tubing and BioPure components and are supplied ready to use.

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

MilliporeSigma, the North American life-sciences business of Germany’s Merck KGaA, added a 2000-L single-use bioreactor to its facility in Massachusetts.

The authors provide their perspectives on shipping validation.

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.

Millipore Express PHF hydrophilic, sterilizing-grade filters from EMD Millipore offer faster flow rates to speed the process or reduce the process footprint.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

Better process development is creating industry benchmarks for bioprocessing.

GE Healthcare Life Sciences and Emerson Process Management collaborate in biopharmaceutical manufacturing processes.

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

Better process development is creating industry benchmarks for bioprocessing.

Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Flexsafe 3D Pre-Designed Solutions feature appropriate components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling.

The high cost of disposables is a factor in restricting adoption of single-use devices.